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2025 OCE Annual Report

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2025 OCE Annual Report Webpage Header

 

DIRECTOR'S MESSAGE

R. Angelo de Claro, M.D.

I am honored to be selected as Director of FDA’s Oncology Center of Excellence (OCE) and lead OCE’s unwavering commitment to patient-centered regulatory decision making. Having been at FDA for the past 15 years, I’ve seen major changes at FDA, including new regulations, modernization initiatives, and various reorganizations including changes in leadership. Through it all, FDA staff have supported each other and rose to meet the various challenges over the years. I look forward to working with all of you as we continue the important work and mission of our organization.

As I reflect on the 2025 accomplishments and collaborations in this annual report, it is clear to me that OCE continues to achieve our public health mission and make a meaningful impact to patients. This is due to the institutional resilience of OCE and our review divisions. The collective leadership and expertise ensure that our regulatory excellence continues uninterrupted through periods of change.

OCE continues to innovate and streamline application review without compromising safety and efficacy standards through our current Assessment Aid (AAid) process and Real-Time Oncology Review (RTOR). The OCE Oncology AI program is refocusing its efforts to be regulatory review-oriented and is exploring how AI may impact regulation of oncology drug development. OCE also participated in the Commissioner’s National Priority Voucher (CNPV) to review zongertinib for HER2-mutated lung cancer and teclistamab for multiple myeloma. I am committed to building off OCE’s experience with AAid and RTOR to pioneer review methodologies that set global standards for regulatory excellence.

International collaboration has been a cornerstone of my work at OCE, and it will remain a key focus as Director. Since 2019, I have had the honor of leading OCE’s global clinical sciences program, including coordination of Project Orbis—our groundbreaking initiative that facilitates simultaneous submission and review of oncology marketing applications across multiple regulatory agencies worldwide. I have witnessed firsthand the power of international cooperation in advancing cancer care globally. These partnerships not only expedite access to innovative treatments but also enhance the quality of our regulatory decisions through shared expertise.

Looking toward 2026 and beyond, OCE is prepared and stands ready to meet future challenges with confidence. OCE’s foundation is strong with experienced leadership, innovative programs, global partnerships, and an unwavering commitment to our mission. I look forward to engaging the cancer community through external workshops, advisory committees, and expanded international partnerships. Together—as academics, industry, advocates, and global regulatory partners—OCE is positioned to continue leading the transformation of cancer care to patients through innovative regulation.

Sincerely,
R. Angelo de Claro, M.D.
Director
Oncology Center of Excellence

 

2025 OCE AR FINALDirector's Message


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